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CNAJTZRT Protocol BC Cancer Protocol Summary for Concomitant (Dual Modality) and Adjuvant Temozolomide for Newly Diagnosed Malignant Gliomas with Radiation Protocol Code CNAJTZRT Tumour Group Neuro-Oncology Contact Physician Dr. Brian Thiessen ELIGIBILITY: . Patients with newly diagnosed glioblastoma all variants, Grade 2-4 astrocytoma IDH wild type, and Grade 4 astrocytoma IDH mutant . Karnofsky Performance Status greater than 50, ECOG 0-2 . Adequate renal and hepatic function . Age less than 70 EXCLUSIONS: . Creatinine greater than 1.5X normal . Significant hepatic dysfunction . Pregnant or breast feeding women TESTS: . Baseline and before starting adjuvant temozolomide: CBC and differential, platelets, ALT, Bilirubin, serum creatinine, random glucose (patients on dexamethasone) . During concomitant temozolomide with RT (dual modality): . Weekly CBC and differential . Before week 1 and before week 4: ALT and bilirubin . Before each treatment of adjuvant temozolomide: . Day 1: CBC and differential, platelets, serum creatinine, ALT and bilirubin . Day 22: CBC and differential, platelets . Before cycles #3 and 5 and at completion of adjuvant temozolomide: neuroimaging . If clinically indicated: sodium, potassium, magnesium, calcium, random glucose PREMEDICATIONS: . For concomitant temozolomide with RT (dual modality): ondansetron 8 mg given 30 minutes prior to first dose of temozolomide, then prochlorperazine 10 mg po 30 minutes prior to each subsequent dose of temozolomide . For adjuvant temozolomide: ondansetron 8 mg po 30 minutes prior to each dose of temozolomide BC Cancer Protocol Summary CNAJTZRT Page 1 of 5 Activated: 1 Oct 2004 Revised: 1 Oct 2021 (Eligibility criteria clarified) Warning: The information contained in these documents are a statement of consensus of BC Cancer professionals regarding their views of currently accepted approaches to treatment. Any clinician seeking to apply or consult these documents is expected to use independent medical judgement in the context of individual clinical circumstances to determine any patient's care or treatment. Use of these documents is at your own risk and is subject to BC Cancer's terms of use available at www.bccancer.bc.ca/terms-of-use TREATMENT: Drug Dose* BC Cancer Administration Guideline temozolomide Concomitant with RT: PO 75 mg/m2 po daily preferably 1 h prior to RT especially in the first week of treatment, and in A.M. on days without RT until completion of RT (usual duration 6 weeks) Adjuvant treatment starting 4 wks after RT: 150 mg/m2 once daily x 5 d (d 1 to 5) every 28 d x 6 cycles * refer to Temozolomide Suggested Capsule Combination Table for dose rounding . Dose may be increased to 200 mg/m2 for the second cycle of adjuvant therapy if no significant hematologic, hepatic or other toxicity is noted (see below) . Trimethoprim/sulfamethoxazole DS one tablet po q Monday, Wednesday and Friday is recommended for patients on concomitant or adjuvant temozolomide if requiring dexamethasone for longer than 4 weeks . Discontinue for clinical or radiographic progression. DOSE MODIFICATIONS: 1. Hematological For Concomitant Temozolomide with RT Weekly CBC: ANC (x109/L) Platelets (x109/L) Dose greater than or and greater than or 100% equal to 1.5 equal to 100 1.0 to less than or 75 to less than 100 Delay temozolomide until counts recover 1.5 less than 1.0 or less than 75 Discontinue temozolomide BC Cancer Protocol Summary CNAJTZRT Page 2 of 5 Activated: 1 Oct 2004 Revised: 1 Oct 2021 (Eligibility criteria clarified) Warning: The information contained in these documents are a statement of consensus of BC Cancer professionals regarding their views of currently accepted approaches to treatment. Any clinician seeking to apply or consult these documents is expected to use independent medical judgement in the context of individual clinical circumstances to determine any patient's care or treatment. Use of these documents is at your own risk and is subject to BC Cancer's terms of use available at www.bccancer.bc.ca/terms-of-use For Adjuvant Temozolomide Day 1: ANC (x109/L) Platelets (x109/L) Dose greater than or and greater than or 100% equal to 1.5 equal to 100 less than 1.5 or less than 100 Delay* * Follow CBC weekly and re-institute temozolomide at one dose level lower (150 mg/m2 or 100 mg/m2) if ANC recovers to greater than 1.5 x 109/L and platelets recover to greater than 100 x 109/L within 3 weeks Day 22: ANC (x109/L) Platelets (x109/L) Dose greater than or and greater than or 100% equal to 1.0 equal to 50 less than 1.0 or less than 50 Reduce one dose level** **Dose levels are 200 mg/m2, 150 mg/m2 and 100 mg/m2 • Note: Dose reductions below 100 mg/m2 are not permitted. Temozolomide should be discontinued for repeat grade 3 or 4 hematologic toxicity (ANC less than 1 x 109/L, platelets less than 50 x 109/L) at the 100 mg/m2 dose. 2. Renal dysfunction: Dose modification required for creatinine greater than 2 x upper limit of normal. Reduce to 100 mg/m2 and discontinue if no resolution of renal dysfunction at this dose. BC Cancer Protocol Summary CNAJTZRT Page 3 of 5 Activated: 1 Oct 2004 Revised: 1 Oct 2021 (Eligibility criteria clarified) Warning: The information contained in these documents are a statement of consensus of BC Cancer professionals regarding their views of currently accepted approaches to treatment. Any clinician seeking to apply or consult these documents is expected to use independent medical judgement in the context of individual clinical circumstances to determine any patient's care or treatment. Use of these documents is at your own risk and is subject to BC Cancer's terms of use available at www.bccancer.bc.ca/terms-of-use 3. Hepatic Dysfunction For Concomitant Temozolomide with RT Bilirubin (micromol/L) ALT Dose less than 25 and less than or equal 100% to 2.5 x ULN greater than or equal to 25 or greater than 2.5 x Delay*** ULN *** Follow LFTs weekly and re-institute temozolomide at 75 mg/m² if Bilirubin recovers to less 25 micromol/L and ALT recovers to less than or equal to 2.5 x ULN Note: Dose reductions below 75 mg/m2 are not permitted. Radiation Therapy to continue without temozolomide until recovery of LFTs. For Adjuvant Temozolomide Bilirubin (micromol/L) ALT Dose less than 25 and less than or equal 100% to 2.5 x ULN 25 to 85 or 2.6 to 5 x ULN Reduce one dose level** greater than 85 or greater than 5 x Delay*** ULN ** Dose levels are 200 mg/m², 150 mg/m² and 100 mg/m² *** Follow LFTs weekly and re-institute temozolomide at 100 mg/m² if Bilirubin recovers to less than 85 micromol/L and ALT recovers to less than 5 x ULN • Note: Dose reductions below 100 mg/m2 are not permitted. Temozolomide should be discontinued for repeat Bilirubin greater than 85 micromol/L and repeat ALT greater than 5 x ULN BC Cancer Protocol Summary CNAJTZRT Page 4 of 5 Activated: 1 Oct 2004 Revised: 1 Oct 2021 (Eligibility criteria clarified) Warning: The information contained in these documents are a statement of consensus of BC Cancer professionals regarding their views of currently accepted approaches to treatment. Any clinician seeking to apply or consult these documents is expected to use independent medical judgement in the context of individual clinical circumstances to determine any patient's care or treatment. Use of these documents is at your own risk and is subject to BC Cancer's terms of use available at www.bccancer.bc.ca/terms-of-use PRECAUTIONS: 1. Neutropenia: Fever or other evidence of infection must be assessed promptly and treated aggressively. 2. Thrombocytopenia: Day 22 platelet counts less than 50 x 109/L should be monitored at least twice weekly until recovering. Platelet counts less than 20 x 109/L and falling should be treated with platelet transfusion. 3. Pneumocystis Jiroveci (previously Carinii) pneumonia (PJP): Occasional reports of PJP in patients receiving concomitant or adjuvant Temozolomide have occurred. Prophylaxis as described above is recommended for patients receiving Temozolomide. Call Dr. Brian Thiessen or tumour group delegate at (604) 877-6000 or 1-800-663- 3333 with any problems or questions regarding this treatment program. References1: 1. Stupp R, Mason WP, van den Bent MJ, et al. Radiotherapy plus concomitant and adjuvant temozolomide for glioblastoma. N Engl J Med 2005;352(10):987-96. BC Cancer Protocol Summary CNAJTZRT Page 5 of 5 Activated: 1 Oct 2004 Revised: 1 Oct 2021 (Eligibility criteria clarified) Warning: The information contained in these documents are a statement of consensus of BC Cancer professionals regarding their views of currently accepted approaches to treatment. Any clinician seeking to apply or consult these documents is expected to use independent medical judgement in the context of individual clinical circumstances to determine any patient's care or treatment. Use of these documents is at your own risk and is subject to BC Cancer's terms of use available at www.bccancer.bc.ca/terms-of-use .
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